Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation

Vanderbilt University Medical Center

Status and phase: Terminated; Phase 2

Conditions: Hypertension

Treatments: Drug: Abatacept; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02232880

121740

Details and patient eligibility

About

The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug Administration to treat rheumatoid arthritis, may help blood pressure medications to work better. This will be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. We expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
• having a systolic blood pressure >150 mmHg in the clinic and daytime average >150 mmHg on ambulatory blood pressure monitoring

Exclusion criteria

• Medical history of secondary cause of hypertension, severe obesity (BMI >35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
• Inability to return for abatacept treatment and follow-up for 24 weeks.
• Inability to understand or complete study-related assessments.
• Current abuse of drugs or alcohol.
• Receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
• Evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (HIV)
• Risk for tuberculosis
• Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin < 8.5 g/dL, white blood cell count < 3000/mm3, platelets < 100,000/mm3, creatinine > 2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase > 2 times the ULN.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups, including a placebo group

abatacept

Active Comparator group

Description:

Subjects randomized to abatacept weighing 60 to 100 kg will receive 750 mg, and those \>100 kg will receive 1000 mg abatacept by intravenous infusion at 0 \[randomization\], 2, and 4 weeks and then every 4 weeks thereafter for a total of 24 weeks. All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.

Treatment:

Drug: Abatacept

placebo

Placebo Comparator group

Description:

Subjects randomized to placebo will receive 100 ml normal saline by intravenous infusion at 0 \[randomization\], 2, and 4 weeks and then every 4 weeks thereafter for a total of 24 weeks. All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.

Treatment:

Drug: Placebo